Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37753–37776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2014
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM...
K133861 · LIT
Ostial Corporation
Cardiovascular · 195d
Cleared Jul 02, 2014
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
K140055 · MAX
Titan Spine, LLC
Orthopedic · 173d
Cleared Jul 02, 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY...
K140129 · DQE
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Jul 02, 2014
AP EXPANDABLE XLIF SYSTEM
K140162 · MAX
Nuvasive, Inc.
Orthopedic · 161d
Cleared Jul 02, 2014
SKYHAWK LATERAL PLATE SYSTEM
K140260 · KWQ
Orthofix, Inc.
Orthopedic · 149d
Cleared Jul 02, 2014
ARROW GPSCATH BALLOON DILATATION CATHETER
K140351 · LIT
Hotspur Technologies,Inc Subsidiary...
Cardiovascular · 141d
Cleared Jul 02, 2014
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
K140512 · EBF
Juno Dentistry LP
Dental · 124d
Cleared Jul 02, 2014
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K140572 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 118d
Cleared Jul 02, 2014
NAVIO
K140596 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 02, 2014
FLOW-NAIL
K140601 · HSB
Flow-Fx, LLC
Orthopedic · 114d
Cleared Jul 02, 2014
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
K140685 · NYL
Sybron Endo
Dental · 106d
Cleared Jul 02, 2014
ISOSEED
K140849 · KXK
Eckert & Ziegler Bebig GmbH
Radiology · 90d
Cleared Jul 02, 2014
MCKESSON RADIOLOGY
K140909 · LLZ
Mckesson Medical Imaging Company
Radiology · 84d
Cleared Jul 02, 2014
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
K141369 · IYN
Philips Ultrasound, Inc.
Radiology · 40d
Cleared Jul 02, 2014
SPHYGMOMANOMETER
K141392 · DXQ
Suzhou JJ Meter Co., Ltd.
Cardiovascular · 36d
Cleared Jul 02, 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · GWO
Jeil Medical Corporation
Neurology · 30d
Cleared Jul 02, 2014
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
K141485 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 27d
Cleared Jul 02, 2014
X-REPAIRSL
K141499 · FTL
Synthasome, Inc.
General & Plastic Surgery · 26d
Cleared Jul 02, 2014
AVREO INTERWORKS SYSTEM
K141556 · LLZ
Avreo, Inc.
Radiology · 20d
Cleared Jul 02, 2014
RS80A DIAGNOSTIC ULTRASOUND SYSTEM
K141620 · IYN
Samsung Medison Co., Ltd.
Radiology · 15d
Cleared Jul 01, 2014
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM,...
K132036 · MSX
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 365d
Cleared Jul 01, 2014
DRE VENTURA
K132903 · BSZ
Dre Medical, Inc.
Anesthesiology · 288d
Cleared Jul 01, 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · KWP
K2m, Inc.
Orthopedic · 249d